Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are… (NCT01200602) | Clinical Trial Compass
TerminatedPhase 2
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
Stopped: The study closed due to slow accrual.
United States1 participantsStarted 2011-03
Plain-language summary
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
* ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
* Negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
Exclusion Criteria:
* Receiving tube feedings or parenteral nutrition
* Evidence of ascites
* Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
* Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\> 5 episodes/week)
* History of unresectable brain tumor or cancer metastatic to the brain
* History of thromboembolic disease
* Insulin-requiring diabetes
* Congestive heart failure and/or uncontrolled hypertension
* Anticoagulation
* Previous history of thrombosis (personal and immediate family)
* Concurrent corticosteroid therapy (except as an antiemetic)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Who Maintain Weight or Experience Weight Gain